Director CMC Operations
Abarca Health- Full Time
- Senior (5 to 8 years)
Candidates should possess a Bachelor’s degree in business or a scientific/technical field, and a minimum of 15 years’ experience in multinational pharmaceutical/biopharmaceutical organizations with global experience, including multi-site Operations/Quality roles. Extensive cGMP knowledge is required, and previous experience with Large Molecule manufacturing is preferred. The candidate must also demonstrate the ability to optimally collaborate with others, lead, empower, and influence remote teams, and experience developing others.
The Senior Director Quality, Large Molecule is responsible for ensuring medicines are manufactured safely and delivered on time, maintaining all Quality standards, regulatory requirements, and customer expectations. Key responsibilities include developing and implementing quality plans, fostering positive relationships with customers and regulators, emphasizing on-time delivery through compliance, encouraging a right-first-time culture, monitoring quality system metrics, ensuring inspection readiness, interfacing with regulatory authorities, developing resource strategies, and ensuring PPI (Practical Process Improvement) is adopted across the quality organization. The role also involves representing the company externally and managing key accounts.
Provides life sciences products and services
Thermo Fisher Scientific offers a variety of products and services that support scientific research and healthcare, including laboratory equipment, reagents, and software solutions. Their products are used in applications like protein biology, real-time PCR, and sequencing, serving clients such as academic institutions and pharmaceutical companies. Unlike competitors, Thermo Fisher emphasizes customer support and education, helping clients optimize their experiments. The company's goal is to be a leading provider of life sciences solutions that contribute to a healthier and safer world.